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FDA Import Refusal SCS-9637208-5/11/1D — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806559

The FDA refused shipment SCS-9637208-5/11/1D from Roche Diagnostics GmbH (Germany) on May 2, 2025. The refused product falls under Devices — SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE. Cited charges: 118,3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 2, 2025
Country
Germany
Product Category
Devices
Product Code
79FMK SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
Charges
118,3280,341

Recent inspections

  • 1177109 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103444 (VAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057452 (NAI Thu Apr 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993103 (NAI Fri Nov 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973782 (NAI Fri Apr 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

FDA data resources